FDA 483 - EUROMI S.A. - March 02, 2023

From February 27 to March 2, 2023, the FDA inspected the manufacturing facility of EUROMI S.A. in Andrimont, Belgium. The inspection, led by Investigator Michelle L. Johnson, focused on the firm"s compliance with medical device quality system requirements. The primary violation identified was a failure to submit a Medical Device Report (MDR) within the required 30-day timeframe. Specifically, the firm received a complaint in June 2021 regarding a device malfunction that could potentially cause or contribute to serious injury or death if it recurred, yet failed to report this to the agency. This is a repeat violation, as the same issue was noted during a previous inspection in 2017. Under the Federal Food, Drug, and Cosmetic Act, the company is responsible for conducting internal audits and maintaining a reporting system that identifies safety concerns promptly. While the Form 483 represents preliminary findings rather than a final compliance determination, the firm"s director, David Leleu, has promised to take corrective actions. EUROMI S.A. is expected to submit a formal response outlining their planned improvements and must ensure their quality system effectively captures and reports significant malfunctions to prevent future regulatory issues and ensure user safety.